ESSENTIAL WEIGHT LOSS (ammonium bromatum, fucus vesiculosus, natrum sulphuricum, nicotinamidum, spongia tosta, thiaminum hydroch

United States - English - NLM (National Library of Medicine)

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Active ingredient:
AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06), FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M), SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4), SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID), THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J), PYRIDOXINE HYDROCHLORIDE
Available from:
Integrative Health Alliance
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Safe weight management Safe weight management
Authorization status:
unapproved homeopathic
Authorization number:
69207-0001-1

ESSENTIAL WEIGHT LOSS- ammonium bromatum, fucus vesiculosus, natrum sulphuricum,

nicotinamidum, spongia tosta, thiaminum hydrochloricum, pyridoxinum hydrochloricum,

riboflavinum, thyroidinum (bovine), calcarea carbonica, graphites liquid

Integrative Health Alliance

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for

safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

DRUG FACTS:

ACTIVE INGREDIENTS:

AMMONIUM BROMATUM 3X, FUCUS VESICULOSUS 3X, NATRUM SULPHURICUM 3X,

NICOTINAMIDUM 3X, SPONGIA TOSTA 3X, THIAMINUM HYDROCHLORICUM 4X,

PYRIDOXINUM HYDROCHLORICUM 6X, RIBOFLAVINUM 6X, THYROIDINUM (BOVINE)

6X, CALCAREA CARBONICA 12X, GRAPHITES 12X

INDICATION FOR USE:

Safe weight management

WARNINGS:

If pregnant or breast feeding, do not use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control

Center right away.

Do not use if tamper evident seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control

Center right away.

DIRECTIONS:

Adults: Take 10 drops orally 3 times a day. Take 30 minutes before eating.

Shake well before using. Store at room temperature away from light.

Consult a physician for use in children under 12 years of age.

INDICATION FOR USE:

Safe weight management

INACTIVE INGREDIENTS:

Demineralized Water, Ethanol 25%

QUESTIONS:

Manufactured for and distributed by

Integrative Health Alliance

1089 Granada Blvd Ste 3

Ormond Beach, FL 32174

PACKAGE LABEL DISPLAY:

ESSENTIAL

WEIGHT LOSS

HOMEOPATHIC

Promotes Increased

Metabolism*

Enhances Energy Levels*

Regulates Appetite*

25%Ethanol

30 ml (1 fl oz)

Made in USA

*These statements have not been evaluated by the Food and Drug Administration.

This product is not intended to treat, cure or prevent any disease.*

ESSENTIAL WEIGHT LOSS

ammonium bromatum, fucus vesiculosus, natrum sulphuricum, nicotinamidum, spongia tosta, thiaminum

hydrochloricum, pyridoxinum hydrochloricum, riboflavinum, thyroidinum (bovine), calcarea carbonica, graphites

liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 20 7-0 0 0 1

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AMMO NIUM BRO MIDE (UNII: R0 JB3224WS) (BROMIDE ION - UNII:9 529 0 2IX0 6 )

AMMONIUM BROMIDE

3 [hp_X]

in 1 mL

FUCUS VESICULO SUS (UNII: 535G2ABX9 M) (FUCUS VESICULOSUS -

UNII:535G2ABX9 M)

FUCUS VESICULOSUS

3 [hp_X]

in 1 mL

SO DIUM SULFATE (UNII: 0 YPR6 5R21J) (SODIUM SULFATE ANHYDROUS -

UNII:36 KCS0 R750 )

SODIUM SULFATE

3 [hp_X]

in 1 mL

NIACINAMIDE (UNII: 25X51I8 RD4) (NIACINAMIDE - UNII:25X51I8 RD4)

NIACINAMIDE

3 [hp_X]

in 1 mL

SPO NGIA O FFICINALIS SKELETO N, RO ASTED (UNII: 1PIP39 4IID) (SPONGIA

OFFICINALIS SKELETON, ROASTED - UNII:1PIP39 4IID)

SPONGIA OFFICINALIS

SKELETON, ROASTED

3 [hp_X]

in 1 mL

THIAMINE HYDRO CHLO RIDE (UNII: M5726 0 0 E5P) (THIAMINE ION -

UNII:4ABT0 J9 45J)

THIAMINE HYDROCHLORIDE

4 [hp_X]

in 1 mL

PYRIDO XINE HYDRO CHLO RIDE (UNII: 6 8 Y4CF58 BV) (PYRIDOXINE -

UNII:KV2JZ1BI6 Z)

PYRIDOXINE

6 [hp_X]

in 1 mL

RIBO FLAVIN (UNII: TLM29 76 OFR) (RIBOFLAVIN - UNII:TLM29 76 OFR)

RIBOFLAVIN

6 [hp_X]

in 1 mL

THYRO ID, BO VINE (UNII: MN18 OTN73W) (THYROID, BOVINE - UNII:MN18 OTN73W)

THYROID, BOVINE

6 [hp_X]

in 1 mL

O YSTER SHELL CALCIUM CARBO NATE, CRUDE (UNII: 2E328 21G6 I) (OYSTER

SHELL CALCIUM CARBONATE, CRUDE - UNII:2E328 21G6 I)

OYSTER SHELL CALCIUM

CARBONATE, CRUDE

12 [hp_X]

in 1 mL

GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)

GRAPHITE

12 [hp_X]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 20 7-

0 0 0 1-1

30 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

12/0 3/20 14

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

12/0 3/20 14

Labeler -

Integrative Health Alliance (043368329)

Registrant -

Apotheca Company (844330915)

Integrative Health Alliance

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Apo the c a

Co mpany

8 44330 9 15

manufacture(6 9 20 7-0 0 0 1) , api manufacture(6 9 20 7-0 0 0 1) , label(6 9 20 7-0 0 0 1) ,

pa c k(6 9 20 7-0 0 0 1)

Revised: 11/2019

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